Comparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy

NCT07650760 | Recruiting Phase 4

• 1 other identifier: WMC/ERC/IRB/134
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. A total of 106 patients divided into two equal groups, with one group receiving bupivacaine and the other treated using normal saline(control).Previous studies on the subject found that bupivacaine significantly reduced postoperative pain. Although conventional intravenous analgesics remain widely used, bupivacaine may be a better option, especially in difficult surgical cases.

Conditions

Postoperative Pain

Keywords

laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Post operative pain relief

  The study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.

  From the completion of the procedure til one hour after surgery

Study Arms (2)

Experimental : group A: bupivacaine

EXPERIMENTAL

Group A is the arm where patients have received intraperitoneal bupivacaine during laparoscopic gallbladder surgery, and their post operative pain is compared .

Drug: Bupivacain

Placebo : group B: saline

PLACEBO COMPARATOR

Placebo : group B: saline Group B is the arm where patients have received only intraperitoneal normal saline .

Drug: Saline (0.9% NaCl)

Interventions

Bupivacain DRUG

In group A intraperitoneal bupivacaine is used for pain relief

Also known as: Group A

Experimental : group A: bupivacaine

Saline (0.9% NaCl) DRUG

In group B intraperitoneal saline is used for pain relief as placebo.

Also known as: Group B

Placebo : group B: saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult consented patients of any gender aged 18 to 60 years Fit to undergo elective laparoscopic cholecystectomy

You may not qualify if:

• Patients who had developed choledocholithiasis or pancreatitis pre-operatively
• Where conversion to open cholecystectomy is needed intraoperatively
• Pregnant or lactating
• Inability to express pain appropriately, like in psychiatric disorders
• With any contraindication to the use of bupivacaine or normal saline, e.g., hypersensitivity

Sponsors & Collaborators

• Wah Medical college , POF hospital: lead

Study Sites (1)

Wah Medical College, POF Hospital Wah cantt Wāh

Wāh, Punjab Province, 47040, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Muhammad Asad Janjua, MBBS

CONTACT

00923351589093; asad24871@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study was conducted as a double-blinded randomized controlled trial. In this design, the outcome assessor (observer) was blinded to the group allocation, while the operating surgeon was also not aware of the intervention being performed.Blinding was achieved by ensuring that the trained observer responsible for recording postoperative outcomes, including post operative pain, did not know whether bupivacaine or normal saline was used during the procedure. This helped to minimize observer bias in outcome measurement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving post operative pain relief following laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year after publication of article in journal

Locations

PA (1)